Free Webinar on Unique Device Identification (UDI).

2. About MakroCare Over 15 years of Life Sciences Core Consulting experience Year Established Proprietary Frameworks/Tools Global Access Employees Clients Awards • 650+ FTEs • 140+ Consultants • NAVA • Vistaar • RIMtrack • jarTree • TULA • ClinMetanoia • mNAAM • mEDC • mIRT • 1996 • (HQ:NJ,USA) • Privately held • 14 • Global Offices • 8 of Global Top 20 • 150+ Small/Mid-level ISO9001 ISO27001 ISO20000 ISO14155

3. About MakroCare Medical Device Practice Regulatory Compliance • Regulatory Intel & Regulatory Strategy Development • Advisory Support and Roadmap Consulting • Biocompatibility, Assurance cases, Testing requirements • Regulatory Writing and Submissions Development (510k, PMA, , Technical Files, DHF, etc.) • Establishment Registration and Product Listing • Quality management system consulting and implementation • SOPs and Quality Manual Development • Third Party Audits and Oversight • Systems and Utilities Validation • Design Control • Risk Management Clinical Development Post Market Support • Clinical Strategy, Study Designing and management • Monitoring (Central / Onsite) • Clinical Data Management, Stat, Analysis, Writing • eClinical technology • Post market Follow-Up Studies (Regulatory and Marketing) • Scientific / Medical advisory • MDR / Annual Reports / Supplements

4. MakroCare’s Approach Design > Implement > Train > Transfer UDI Compliance Solution Phase 2: Implement Phase 3: Report Phase 1: Design • Consulting and Advisory Support from Serialization, Supply Chain and Compliance Experts • Plan Development • Implementation Guidance • Source Data Identification • Data Mapping • SOP and Procedure Implementation • Database Set-up • Migration / Integration • Initial work volume management • Data Quality and Compliance team

5. MakroCare’s Approach Design > Implement > Train > Transfer UDI Compliance Solution Phase 1: Design Phase 2: Implement Phase 3: Report • HL7 SPL UDI xml tool • Web Based / On-premise • Generate XML FDA Submissions • Manage Submission Lifecycle • Easy-to-Use • Integrated dashboard • Pay-as-per use • Ongoing development for global compliance requirements • Part 11 Compliant

7. Step 1. Developing the UDI compliance plan • Brief senior management on project scope and provide resource requirements with cost • Receive senior management project approval • Build the right team members who are dedicated and have the right complement of product/process knowledge • Define clear roles, accountabilities and responsibilities • Understand the requirements of the Medical Device Regulation • Engage in an approach that will confirm assumptions early and allow for joint agreed adjustment to the plan • Evaluate the supply chain business processes • Produce gap assessment and generate gap findings and conclusions • Prepare for innovative and sustainable change to the go-forward environment - monitor publications • Plan and provide that product experts enable knowledge transfer • Develop a plan for Change Management

8. Step 2. Understanding the Machine Readable Technology • That number on the medical device, It's not just a number....It means something • Standard product identifier • Reach out to the global community • Benefit to the medical community • Better traceability • Expedite recalls

9. Step 3. Change Management • Create compelling story or business case • Build a team who are fully committed to the change initiative • Create the vision • Communication, Communication, Communication • Start with "short term" wins

10. Step 4. Risk Assessment keeping the system agile for future changes • Proactively identify and manage risks • Assess Labeling changes - Global Packaging • Supply Chain continuity planning

11. Step 5. Implementation of UDI plan across the value chain • Review with project team key points of requirement • Identify the representative products for assessments • Build implementation road map, resourcing including cost • Identify low impact product device for implementation as pilot project • Present implementation recommendations and validate with stakeholders • Parallel process low impact product device • Evaluate and communicate results of "pilot" product

12. Step 6. Identifying the data sources for FDA reporting • Develop UDI data source map • Develop UDI database for FDA Reporting • Submit information to FDA which will be used to populate the Unique Device Identification Database (GUDID)

13. Compliance Dates

14. Compliance Dates (Cont.)

15. UDI formats by FDA-Accredited Issuing Agency This document contains information and links related to the format of the unique device identifier (UDI) for each FDA-accredited issuing agency.  Each FDA-accredited issuing agency has a unique UDI format that has been approved by FDA during the initial accreditation process.  Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation.  Please contact the issuing agency directly to obtain a UDI and for any additional questions regarding the creation or implementation of the formats. Please note that standards development organizations that are helping to promote standard adoption of UDI in electronic health information are currently working on recommendations for UDI representation and transmission. When available, links to these documents will be available at the UDI webpage: www.fda.gov/udi GS1® Issuing Agency

16. Health Industry Business Communications Council® (HIBCC) Issuing Agency

17. Health Industry Business Communications Council® (HIBCC) Issuing Agency (Cont.)

18. International Council for Commonality in Blood Banking Automation (ICCBBA) Issuing Agency

19. International Council for Commonality in Blood Banking Automation (ICCBBA) Issuing Agency (Cont.)

20. UDI Issuing Agencies • 1. Firm Name: GS1Address: Princeton Pike Corporate Center, 1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648Contact Person: Siobhan O’Bara, Senior Vice President - Industry EngagementPhone: (609) 620-8046Email: sobara@gs1us.orgWeb Site: http://www.gs1.orgDate of Initial Accreditation: December 17, 2013Initial Accreditation Granted through: December 17, 2016 • Application • Approval Letter • Information on Using the GS1 System for UDI Requirements • 2. Firm Name: Health Industry Business Communications Council (HIBCC)Address: 2525 E. Arizona Biltmore Circle, Suite 127, Phoenix, AZ 85016Contact Person: Robert A. Hankin, PhD., President and CEOPhone: (602) 381-1091Email: rhankin@hibcc.orgWeb Site: http://www.hibcc.orgDate of Initial Accreditation: December 26, 2013Initial Accreditation Granted through: December 26, 2016 • Application • Approval Letter • 3. Firm Name: ICCBBAAddress: PO Box 11309, San Bernardino, CA 92423-1309Contact Person: Pat Distler, Technical DirectorPhone: (909) 793-6516Email: pat.distler@iccbba.orgWeb Site: http://www.iccbba.orgDate of Initial Accreditation: February 12, 2014Initial Accreditation Granted through: February 12, 2017 • Application • Approval Letter

21. Project Timeline New Regulation Compliance

22. Contact: Jim Petragnani and Aaryak Joshi medtech@makrocare.com +1-973-481-0100 extn 3043 www.makrocare.com One Washington Park, Suite 1303, Newark, - 07102, NJ (USA)